Nov. 4, 2011 -- The FDA has approved rivaroxaban (Xarelto) for prevention of stroke in patients with nonvalvular atrial fibrillation, making it the first oral direct factor Xa inhibitor to be approved for stroke prevention.
Rivaroxaban, an oral direct factor Xa inhibitor, had already been approved for the prevention of deep vein thrombosis in patients undergoing joint replacement surgery.
The approval was supported by findings from the ROCKET-AF trial, which showed that rivaroxaban was as effective as warfarin at preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Rivaroxaban was associated with a similar rate of major bleeding but a significantly lower rate of intracranial hemorrhage.
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However, one of three FDA reviewers who scoured the trial data felt that drugmaker Johnson & Johnson failed to prove that the drug is as effective as warfarin because of suboptimal warfarin administration in the trial. The reviewer recommended against approval in documents prepared for the FDA's Cardiovascular and Renal Drugs Advisory Committee meeting in September.
Nevertheless, the committee -- by a vote of 9-2 with one abstention -- recommended approval for the stroke prevention indication.
Rivaroxaban had already been approved by the FDA in July for the prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery. That okay was based on the EINSTEIN DVT trial, which showed that rivaroxaban was noninferior to enoxaparin plus warfarin for preventing recurrent deep vein thrombosis.
Rivaroxaban becomes the second in a wave of new anticoagulants aimed at improving on warfarin's success in preventing stroke in patients with atrial fibrillation to be approved by the FDA. Last year, dabigatran (Pradaxa), a direct thrombin inhibitor, received approval.
There are other oral direct factor Xa inhibitors under development for stroke prevention in atrial fibrillation, including apixaban, which was recently shown to be superior to warfarin in the ARISTOTLE trial, and edoxaban, which is currently being evaluated in the ENGAGE trial.